Enabling Companies to Transform Scientific Discoveries to Novel Treatments for better Healthcare
Techsol offers full-range Clinical Research Services with a focus to deliver high quality, regulatory compliant and cost-effective clinical development results. With our expertise and experience, we partner with sponsors as a trusted scientific solutions provider to bring novel medicines faster to the market.
We have deep scientific and regulatory knowledge to formulate the right study design, selection of a suitable reference product, coordinating with stakeholders, laying pathways for regulatory approvals, completing patient recruitment as per Inclusion and Exclusion Criteria, evaluating statistical considerations based on immunogenicity and safety, timely coordination amongst stakeholders and so on to successfully complete different types of biopharmaceutical clinical trials.
How We Can Help
Establishing the safety profile of a medicinal product is a crucial step and we understand the nuances to get accurate results to account for drug pharmacology (PK/PD), biological activity, maximum tolerated dose (MTD) and so on.
Following are our key specialties for Biopharma clinical studies:
- Toxicology Studies
- Safety Pharmacology Assessment
- Bio-Analytical Services
As a continuum to early phase development, we have the expertise to complete safety assessment, dosage and efficacy determination by conducting Phase I, II and III clinical studies.
With Techsol’s interconnected hospital and healthcare organizations network, we have a broad outreach to a wide-variety of targeted patient populations, qualified principal investigators, and site personnel to timely achieve subject recruitment and complete the study conduct phase in a regulatory compliant manner.
Evaluating the readiness state of a regulatory submission requires meticulous planning and continuous team coordination. At Techsol, we have teams unified with our proprietary digital collaboration platform to facilitate fast and streamlined process execution.
Our experience in data submissions, and knowledge of data exchange standards allows fast and accurate data submissions to global regulatory bodies.
- Extensive experience in managing different types of biologics clinical studies
- Access to a broad patient pool network
- Deep scientific knowledge that drives risk-based clinical development
- Technology and infrastructure to deliver results in a transparent and regulatory compliant manner